Florida bans driver's licenses of immigrants living in US illegally

 Florida will no longer accept driver's licenses issued by some other U.S. states to immigrants living in the country illegally under a law signed by Governor Ron DeSantis as he seeks the 2024 Republican presidential nomination.

The Florida law, which took effect on July 1, is "the strongest anti-illegal immigration legislation in the country," the governor's office said in a press release on Wednesday.

The out-of-state licenses, designed specifically for unauthorized immigrants and deemed invalid by the Florida Department of Highway Safety and Motor Vehicles, are from Connecticut, Delaware, Hawaii, Rhode Island and Vermont.

The list includes out-of-state licenses that indicate "Not for Federal Identification" or "Driving Privilege Only." Those found to be driving in Florida with such licenses will face citations and other penalties.

The law also prohibits anyone without immigration documentation from getting a Florida driver's license.

"Someone who is in our country illegally and has violated our laws should not possess a government-issued ID which allows them access to state-funded services and other privileges afforded to lawful residents," DeSantis said in the release.

DeSantis has sought to draw conservative voters who favor hardline immigration policies away from Republican front-runner Donald Trump, the former president who leads DeSantis by more than 20 percentage points in national opinion polls.

The bill also blocks counties and municipalities from providing funds to individuals or organizations that issue identification documents to people without proof "of lawful presence in the United States."

Hospitals are required to collect patients' immigration status as part of their intake process.

Mexico's government assailed the law as racial profiling and a hate crime. "Criminalization is not the way to solve the issue of undocumented immigration," a Mexican government statement said on Saturday.

"The existence of transnational labor markets, and the intense ties of trade and tourism between Mexico and Florida, cannot be overlooked by measures inspired by xenophobic and white nationalist sentiments," it said.

https://www.marketscreener.com/news/latest/Florida-bans-driver-s-licenses-of-immigrants-living-in-US-illegally--44284034/

Venezuela to regulate private shipments of food and medicine, sources say

 Venezuela is planning to introduce new regulations on courier shipments of food, medicine and other products in an effort to raise more taxes, one government and two private sector sources said on Thursday.

So-called "door-to-door" courier services are used by some retailers to bring in goods such as toilet paper, detergent and diapers from countries including the United States.

They were originally used by individuals to circumvent shortages in Venezuela's crisis-hit economy, but de facto dollarization has led retailers to also take advantage of the fewer restrictions and tax exemptions on the couriers.

The government provides no official figures on the volume of such shipments, which arrive by boat and plane. But in a bid to raise tax revenue amid U.S. sanctions and a faltering oil industry, the government is preparing to regulate them, the sources said.

"The door-to-doors will remain and we are working on regulations," said a government source, without providing further details.

Vice President Delcy Rodriguez and other officials met with business people in late June to discuss regulation, but no specific measures came out of the meeting, the two private sector sources said.

This week several courier companies, who are generally local outfits, said on social media they would suspend shipments as they await official action.

Further regulations could make shipments - which can sometimes even include furniture - more expensive.

Retailers who receive shipments can often offer consumers lower prices on goods compared to local purchases in Venezuela, where inflation was 429% in the 12 months to May, according to the central bank.

The communications ministry did not respond to a request for comment. 

https://www.marketscreener.com/news/latest/Venezuela-to-regulate-private-shipments-of-food-and-medicine-sources-say--44283351/

US wants coalition of nations to engage China in curbing synthetic drugs

 The U.S. wants other countries to engage China on limiting the flow of synthetic drugs, the State Department's top official on narcotics said on Thursday, as Washington complains of a lack of cooperation from Beijing to combat illegal trade in the dangerous substances.

On the eve of a U.S.-led conference on the issue, Assistant Secretary of State for International Narcotics and Law Enforcement Todd Robinson said China needed to do more to disrupt illicit synthetic drug supply chains, but that it was still unclear if China would join the meeting.

"We've invited China. We don't have any indication at the moment that they're going to participate," Robinson told reporters on a call, adding that though Beijing "had not engaged" with U.S. officials on the issue in recent months, Washington still actively sought its help.

U.S. Secretary of State Antony Blinken on Friday will host the first virtual meeting of at least 84 countries to set up a "global coalition" to combat synthetic drugs, part of a Biden administration policy to curb the highly addictive painkiller fentanyl that has fueled the country's opioid crisis.

"This isn't about blame, and this isn't about pressure," Robinson said.

"Part of the reason we're trying to bring this coalition together is to engage other countries in their efforts against the supply chain, and part of their responsibility is going to be engaging with the PRC (People's Republic of China)," he said.

China's embassy in Washington did not immediately respond to a request for comment on the meeting.

China is a major producer of the chemicals that are required to create fentanyl, which is frequently smuggled over the U.S.-Mexico border.

At a time when relations between the geopolitical rivals have deteriorated, China has not been helpful in cracking down on the flow of fentanyl precursor chemicals or on money laundering related to trafficking, according to U.S. officials.

Beijing has said Washington should stop using the fentanyl crisis as a pretext to impose sanctions on Chinese companies, and Chinese state media have repeatedly said addiction and demand for the drug are U.S. domestic problems.

Almost 80,000 Americans died from opioid-related overdoses in 2022, according to the Centers for Disease Control.

The U.S. Justice Department in June filed criminal charges against four Chinese chemical manufacturing companies and eight people over allegations they illegally trafficked the chemicals used to make fentanyl.

https://www.marketscreener.com/quote/index/TOPIX-INDEX-61714390/news/US-wants-coalition-of-nations-to-engage-China-in-curbing-synthetic-drugs-44284129/

Who is eligible for Leqembi?

 The U.S. Food and Drug Administration on Thursday granted standard approval to Eisai and Biogen's Leqembi for patients with Alzheimer's disease.

The FDA decision is expected to trigger broader coverage of the $26,500-a-year drug by the U.S. government's Medicare health plan for people aged 65 and older. Leqembi was granted "accelerated" FDA approval in January, but Medicare restricted coverage only to patients in clinical trials.

WHAT IS LEQEMBI?

Leqembi is an antibody designed to remove sticky deposits of a toxic protein called amyloid beta from the brains of Alzheimer's patients. The drug is administered every two weeks as an intravenous infusion.

Leqembi was shown in a pivotal trial to slow the rate of cognitive decline by 27% compared with a placebo after 18 months.

WHO WILL USE IT?

The FDA label for the drug says it should be started when patients are in the mild cognitive impairment or mild dementia stage of the degenerative brain disease.

The FDA recommends on Leqembi's label that doctors conduct testing for a gene called APOE4 that is associated with a higher risk of Alzheimer's as well as brain swelling associated with amyloid-lowering drugs. The FDA included a "boxed warning" that flags the risk of brain swelling on the label.

The agency does not require APOE4 genetic testing and doctors and patients will need to weigh the risk of brain swelling against the drug's potential benefits.

Around 25% of the population has one copy of the APOE4 gene, while up to 3% have two copies of the gene, according to the National Institute on Aging.

The FDA also warns that doctors should be particularly cautious when considering Leqembi for patients taking anticoagulants, which can also raise the risk of bleeding in the brain.

Eisai has estimated that the number of U.S. patients diagnosed with early Alzheimer's would total around 100,000 in Leqembi's first three years on the market.

More than 6 million Americans have Alzheimer's, according to the Alzheimer's Association.

WHO WILL PAY FOR IT?

Because it is a disease of aging, most Alzheimer's patients are covered by Medicare, which had effectively denied coverage of Leqembi under the accelerated approval it received in January. The drug has a U.S. list price of $26,500 a year.

With standard FDA approval, Medicare has said it will reimburse patients for the treatment as long as their doctors collect data and submit it to a free health agency database, known as a registry.

Medicare is expected to cover about 80% of the cost, with patients at least partially responsible for the other 20%, according to a recent study published in JAMA Internal Medicine.

The study said Leqembi patients could have annual out-of-pocket costs of about $6,600 depending on the state they live in and whether they have supplemental insurance, while some lower-income people who also qualify for Medicaid would pay nothing out-of-pocket.

Eisai also offers support programs to help eligible patients afford the cost of the new drug.

WHERE WILL IT BE AVAILABLE?

Leqembi has been available for doctors to prescribe since its accelerated approval in January, but very few patients have been treated with the drug due to Medicare's payment restrictions.

Eisai said it is expanding efforts to get health centers ready to use Leqembi.

https://www.marketscreener.com/quote/stock/BIOGEN-INC-4853/news/Who-is-eligible-for-the-new-FDA-approved-Alzheimer-s-drug-44284167/

Sen. Bill Cassidy: Smart, practical ways to lower drug prices

 In the 1952 Oscar-winning movie “High Noon,” Gary Cooper’s face was tense and pained as he single-handedly faced a gang of killers. The pain wasn’t acting: Cooper suffered from severe stomach ulcers. He drank milk to get some relief, but clearly, the milk did not work.

Until the late 1970s, the only real option for treating ulcers was surgery. Then the blockbuster drug Tagamet was released, and the need for ulcer surgery plummeted. Now, Tagamet is sold over the counter.

Many formerly debilitating and fatal chronic diseases, genetic conditions, and cancers are now curable or manageable thanks to medical innovation. Treatments that would once have been miraculous are commonplace. But if a patient cannot afford innovative treatments, to them it is as if that innovation never occurred.

As a physician, I treated the uninsured for decades. I saw the tension between the person in front of me who needed affordable medicine and the drug developer motivated by profits to research the new treatments needed to save future patients. Present affordability and future innovation must be balanced. This life experience guides my approach to drug pricing as the ranking member of the Senate’s Health, Education, Labor, and Pensions (HELP) Committee.

Each actor in the system points to another or to unintended consequences of public policy as the source for high pharmaceutical costs. Pharmacy benefit managers, insurance companies, and drug manufacturers will all blame each other, but the problems are diverse and intertwined. Just as Christmas lights cannot be untangled with a pair of scissors, to preserve the benefits of our drug research and production system the causes of high prices must be teased apart.

Congress should thoroughly review the entire supply chain and the public policies that influence it. There are several places where we can begin.

Americans are rightfully concerned that sticker prices for some drugs are too high. Manufacturers can game the regulatory system to delay competition and preserve their ability to charge higher prices. The laws on the books allow them to do this. Congress should close loopholes, such as the “parking” of 180-day exclusivity and abuse of the citizen petition process. The bipartisan Expanding Access to Low-Cost Generics Act of 2023, which was passed out of the HELP Committee in May, aims to prevent this practice by allowing other generic manufacturers to advance in front of the first-filer if that manufacturer does not bring their drug to market in a timely manner.

There is also interest in addressing the potential misuse of the 340B program, a system intended to provide affordable medicines to low-income and uninsured patients. A 340B-qualifying hospital that treats low-income and uninsured patients can use the program to buy outpatient prescription drugs at a discount of 25 percent to 50 percent or more.

However, certain providers that clearly do not treat low-income patients take advantage of the program’s loose requirements to access the discounted drugs to maximize profit. This costs pharmaceutical companies billions. It is plausible companies compensate for this by inflating prices for everyone else. Other bad actors receive the 340B discount but do not pass the savings on to uninsured patients. Congress should increase 340B transparency and accountability to preserve the intent of the program.

Another opportunity for reform comes in pharmacy benefit managers, who have recently been criticized for their role in increasing drug costs. While PBMs have an important role in price negotiation, there can be a conflict of interest. PBMs receive greater rebates from higher sticker prices, which would incentivize promoting drugs with higher sticker prices. In practice, these rebates often do not reach the patient. Instead, they may be used to add to the profits of the insurance companies or the PBMs involved in the transaction, lower the cost of premiums for other patients, or otherwise fail to benefit the patient who is actually paying the bill. This is the “reverse Robin Hood effect.” Those who are sicker subsidize those who are better off. This is wrong.

There are examples of PBMs preferring more expensive insulin instead of a cheaper alternative. This dynamic hurts patients whose cost share is at times based on sticker price.

In May, the HELP Committee voted to pass bipartisan legislation that improves transparency of PBMs so patients can know what they’re expected to pay, and employers have the ability to shop around for the best deal.

The committee also passed bills to speed lower-cost generic drugs coming to market by preventing gamesmanship and abuse of the citizen petition process, preventing the “parking” of 180-day exclusivity, and changing the Orphan Drug Act exclusivity to align with the scope of Food and Drug Administration approval, which would allow more drugs for rare diseases to come to market.

These are a few of the many areas where the HELP committee can untangle this knot. Uncovering and addressing misaligned incentives will reduce the price of drugs and make the system work better for patients.

And unlike policies like price setting or importation that hack away at the entire system for the possibility of short-term benefit, addressing these underlying problems will preserve the incentives to invest in innovation.

We have to reduce the price Americans pay for their medications. This is a priority for Republicans and Democrats alike. We need more stories of diseases and conditions like Gary Cooper’s that are now rarely seen or are much less severe. This will always include a new medicine or treatment, and with our legislation, along with future reforms, we can ensure that these miracle products are not out of reach for Americans. This is how to heal a sick patient.

I look forward to working with my colleagues on both sides of the aisle to continue our work to lower drug costs and improve access to the best possible care for American families.

Dr. Bill Cassidy is the senior senator from Louisiana and ranking member of the Senate Health, Education, Labor and Pensions (HELP) Committee. Before his time in Congress, Dr. Cassidy worked for over 25 years in the Louisiana charity hospital system and taught medical students and residents at LSU Medical School.

https://www.statnews.com/2023/07/05/lower-drug-prices-bill-cassidy-help-committee/

Biden promised a ‘war on cancer’ — but declared war on the cure instead

 When then-Vice President Biden launched the Cancer Moonshot in 2016, there was reason to be optimistic. Decades of rigorous science had transformed many cancers from a death sentence to a manageable chronic disease. New treatment advances — including gene and cell therapies and immunotherapies — were showing stunning results. With support from the biopharmaceutical industry and the help of smart government policies, ending cancer was, and is, an achievable goal.

Unfortunately, while the president promised a war on cancer, he declared a war on the cure instead. As the head of PhRMA, an association representing America’s leading biopharmaceutical research companies, I work with my team to closely follow the policy debate and the impact on innovation. While they may have been well-intended, the Biden administration has adopted a series of policies that attack critical steps needed to bring new treatments out of the lab and to the patients who need them.

First, the administration eroded the foundation of scientific innovation by subverting intellectual property protections. In 2022, the White House caved to foreign competitors and global activists by agreeing at the World Trade Organization ministerial conference to waive IP protections that enabled the development of Covid-19 vaccines.

That caused the first tear in the IP fabric, signaling the United States would no longer vigorously defend the IP rights of researchers. Countries including China and India are now angling to waive IP protections for Covid-19 treatments, including those that could potentially treat cancer and other diseases. The administration has been unwilling to stop this global IP heist.

For life sciences companies, IP is the foundation. The certainty of knowing it will have exclusive rights for a limited time before copies hit the market is what enables companies to make long-term, risky investments into new medicines.

Next, the administration signed legislation giving them the authority to unilaterally determine the value of innovative medicines. Under the guise of “negotiation,” the Inflation Reduction Act (IRA) allows the federal government to set the price of medicines in Medicare.

Every time it has been tried around the world, government price setting reduces patient access to new cures and treatments. According to a recent report we released, patients in the U.S. have access to 85% of new medicines compared with 43% in France and 21% in Canada where governments set the price. Government price setting also leads to less innovation, and in the case of the IRA, cancer research will be especially hard-hit.

For example, the IRA’s price setting provisions disproportionately impact small-molecule medicines — medicines that typically come in pill or tablet form. These small but mighty treatments have a unique ability to target specific processes inside cells that allow tumors to grow and spread. The majority of cancer medicines approved for use today are small molecules.

Medicines typically face generic competition after they’ve been on the market 14 years. But the IRA cuts that time to nine years after FDA approval for small-molecule treatments. The consequences of this “pill penalty” are predictable. In a survey of our member companies, 63% who responded said they plan to shift focus away from small-molecule medicines.

The law’s price setting scheme also threatens research on existing treatments. Research companies often conduct clinical trials to learn whether an already-approved treatment can help more patients with a similar disease or those with different diseases entirely. It can take years to get results that show an approved treatment could benefit other patients.

Consider Xalkori. This targeted oral cancer therapy was first approved in 2011 for the treatment of an advanced non-small cell lung cancer caused by a specific gene abnormality. It would later receive six additional approvals across several patient populations, including one more than a decade after its initial approval.

This is how innovation works. A new analysis that the Partnership for Health Analytic Research prepared for PhRMA found that 61% of small-molecule cancer treatments approved between 2006 and 2012 received additional approvals for indications to treat other forms of cancers, with 41% occurring seven years or more after initial approval.

This post-approval research has been critical in the fight against cancer, as well as pediatric and rare diseases. But if it takes seven years to bring these treatments across the finish line and the government sets the price two years later, then it disincentivizes the clinical research needed to develop these new therapies.

As it writes rules to implement the IRA, the administration is making a bad law worse. Once a treatment is selected for government price setting, the administration intends to sweep in every new form that followed a medicine’s initial approval. This will subject to price controls new treatments that have been available for just a few years or even less.

Finally, the Biden administration is threatening the availability of medicines approved by the FDA through a program that has provided timely access to hundreds of treatments. Accelerated approval has sped the development of new medicines for patients where unmet need is greatest and no alternative or viable treatments exist, while adhering to the same standards for safety and effectiveness as traditional approval. It has been a resounding success since it was first developed during the HIV/AIDS crisis.

Fast forward to today, and the administration is supporting policies that would limit Medicare payment for medicines granted accelerated approval. Once again, those with cancer will be disproportionately harmed. Nearly 70% of medicines with accelerated approval have been in oncology. Companies will be forced to abandon the program if patients cannot access these treatments, and potentially lifesaving medicines will take longer to reach patients than they otherwise would.

The cumulative effect of these misguided decisions will be felt for years to come. They will undermine America’s global leadership and competitiveness. And they will harm our ability to develop new treatments for a whole host of diseases.

Advances in cancer research are not accidents, nor are they inevitable. They emerge from an ecosystem that encourages risk, discipline and drive — one we must preserve and protect. President Biden should end the assault on that ecosystem, and in doing so, help win the fight against cancer.

Steve Ubl is the president and CEO of PhRMA.

https://www.statnews.com/2023/07/06/biden-cancer-moonshot-ira-intellectual-property/

Drinking water from nearly half of U.S. faucets likely contains “forever chemicals”

 Drinking water from nearly half of U.S. faucets likely contains “forever chemicals” that may cause cancer and other health problems, according to a government study released Wednesday.

The synthetic compounds known collectively as PFAS are contaminating drinking water to varying extents in large cities and small towns — and in private wells and public systems, the U.S. Geological Survey said.

Researchers described the study as the first nationwide effort to test for PFAS in tap water from private sources in addition to regulated ones. It builds on previous scientific findings that the chemicals are widespread, showing up in consumer products as diverse as nonstick pans, food packaging and water-resistant clothing and making their way into water supplies.

Because the USGS is a scientific research agency, the report makes no policy recommendations. But the information “can be used to evaluate risk of exposure and inform decisions about whether or not you want to treat your drinking water, get it tested or get more information from your state” about the situation locally, said lead author Kelly Smalling, a research hydrologist.

The U.S. Environmental Protection Agency in March proposed the first federal drinking water limits on six forms of PFAS, or per- and polyfluorinated substances, which remain in the human body for years and don’t degrade in the environment. A final decision is expected later this year or in 2024.

But the government hasn’t prohibited companies using the chemicals from dumping them into public wastewater systems, said Scott Faber, a senior vice president of the Environmental Working Group, an advocacy organization.

“We should be treating this problem where it begins, instead of putting up a stoplight after the accident,” he said. “We should be requiring polluters to treat their own wastes.”

Studies of lab animals have found potential links between PFAS chemicals and some cancers, including kidney and testicular, plus issues such as high blood pressure and low birth weight.

Federal and state programs typically measure exposure to pollutants such as PFAS at water treatment plants or groundwater wells that supply them, Smalling said. In contrast, the USGS report was based on samples from taps in 716 locations, including 447 that rely on public supplies and 269 using private wells.

The samples were taken between 2016 and 2021 in a range of locations — mostly residences but also a few schools and offices. They included protected lands such as national parks; residential and rural areas with no identified PFAS sources; and urban centers with industry or waste sites known to generate PFAS.

Most taps were sampled just once. Three were sampled multiple times over a three-month period, with results changing little, Smalling said.

Scientists tested for 32 PFAS compounds — most of the ones detectable through available methods. Thousands of others are believed to exist but can’t be spotted with current technology, Smalling said.

The types found most often were PFBS, PFHxS and PFOA. Also making frequent appearances was PFOS, one of the most common nationwide.

Positive samples contained as many as nine varieties, although most were closer to two. The median concentration was around seven parts per trillion for all 32 PFAS types, although for PFOA and PFOS it was about four parts per trillion — the limit EPA has proposed for those two compounds.

The heaviest exposures were in cities and near potential sources of the compounds, particularly in the Eastern Seaboard; Great Lakes and Great Plains urban centers; and Central and Southern California. Many of the tests, mostly in rural areas, found no PFAS.

Based on the data, researchers estimated that at least one form of PFAS could be found in about 45% of tap water samples nationwide.

The study underscores that private well users should have their water tested for PFAS and consider installing filters, said Faber of the Environmental Working Group. Filters containing activated carbon or reverse osmosis membranes can remove the compounds.

The USGS study is “further evidence that PFAS is incredibly pervasive and folks who rely on private wells are particularly vulnerable to the harms caused by these chemicals,” Faber said.

https://www.statnews.com/2023/07/06/drinking-water-pfas/